Medico Economic Evaluation of Dermal Substitute Integra® for Coverage of Inferior Limb Traumatic Skin Loss

NCT00906672 | Completed Phase 3 DMC

• 1 other identifier: CHUBX 2008/26
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 7

Brief Summary

Comparison of 2 techniques of surgery on patients with inferior limb traumatic wounds: the innovative technique Integra® and the technique of reference: the flap surgery.

Conditions

Leg Injuries; Ankle Injuries; Foot Injuries

Keywords

Dermal substitute Integra®; Flap; graft; traumatic wound; medico economic costs; esthetical and functional scar results

Outcome Measures

Primary Outcomes (3)

• Occurrence of at least one complication requiring a surgical re-intervention

  Within the first 18 months after surgery

• Persistence of an important / major trouble of the scar measured by a "scar-trouble scale" filled in by the patient.

  at 18 month-follow up

• Auto-evaluation of patient's scar esthetical result with a visual analog scale.

  at 18 month-follow up

Secondary Outcomes (5)

• Occurrence of all post surgical complications

  Within the first 18 months after surgery

• Duration of hospitalization and healing

  Within the first 18 months after surgery

• Period until return to work and re-start of daily activities

  Within the first 18 months after surgery

• Ïntensity of scar pain during cares evaluated with a visual analog scale and quality of life (EuroQol)

  Within the first 18 months after surgery

• Human and medical requirements

  Within the first 18 months after surgery

Study Arms (2)

INTEGRA®

EXPERIMENTAL

Device: INTEGRA®

Flap technique

ACTIVE COMPARATOR

Procedure: Flap technique

Interventions

INTEGRA® DEVICE

A plaque of dermal substitute Integra® is adjusted to the size of the wound and sutured. A negative pressure bandage is placed on the wound. 7 to 11 days post surgery, the Integra® silicone layer is removed and the neoderm is covered with a skin graft.

INTEGRA®

Flap technique PROCEDURE

A flap is a part of skin, cutaneous tissue or muscle that is taken from an healthy area of the body and put on the damaged area for coverage.

Flap technique

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patient with skin loss traumatic or chronic wound
• wound located from mid third of the leg to distal extremity of feet
• with muscle and/or tendon and/or bone and/or articulation exposure
• requiring a first surgical intervention for the coverage of the skin loss
• patient eligible to the Integra® surgery techniques
• patient with social security affiliation
• written informed consent signed by the patient or representative

You may not qualify if:

• Bone fracture located in the skin loss
• Non traumatic wound
• Wound with muscle exposure only
• Immunocompromised patient
• Allergy to bovine collagen, glycosaminoglycans or silicon
• patient with an healthstate that compromise the 18 months Follow-up
• pregnant women / who intend to become pregnant within the 18 months of follow-up
• Patient under administrative or legal supervision

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (7)

University Hospital

Besançon, 25030, France

Location

Universiy Hospital Bordeaux,

Bordeaux, France

Location

University Hospital

Clermont-Ferrand, 53003, France

Location

University Hospital

Grenoble, 38043, France

Location

University Hospital

Montpellier, 34295, France

Location

Saint Roch Hospital

Nice, 06003, France

Location

University Hospital

Pointe à Pitre, 97159, France

Location

MeSH Terms

Conditions

Leg Injuries; Ankle Injuries; Foot Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Geneviève CHENE, MD-PHD

  USMR (University Hospital, Bordeaux)

  STUDY CHAIR

• Vincent CASOLI, MD-MHD

  University Hospital, Bordeaux

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 21, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 8, 2014

Record last verified: 2014-05

Locations

FR (7)